Steerable access sheath and methods of use

• US 20040044350A1
• Filed: 05/19/2003
• Published: 03/04/2004
• Est. Priority Date: 04/09/1999
• Status: Abandoned Application

• Current Assignee: Nc Evalve
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Thornton, Troy L., Powell, Ferolyn T., Martin, Brian B., Raatikka, Amy R.
• Application Number:
  US10/441,753
• Publication Number:
  US 20040044350A1
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 1/00078 with stiffening means
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/1492 : having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 : by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 : using laser
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 : Barbed implements
• CPC Class Codes: A61B 2017/00588 : Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 : Valvuloplasty
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0158 : with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

Claims

1. An articulatable access system for accessing a body cavity comprising:

a shaft having a proximal end, a distal end, and a central lumen therethrough, wherein the distal end is passable through to the body cavity, the central lumen is sized for passage of an interventional device therethrough and a portion of the shaft comprises a series of articulating members;

at least one pullwire which extends through at least one of the articulating members to move the portion of the shaft into an articulated position; and

an obturator removably positionable in the central lumen and configured to position the portion of the shaft in a first shape.

2. An articulatable access system as in claim 1, further comprising a locking feature to hold the articulating members in the articulated position to direct the device to the body cavity.

3. An articulatable access system as in claim 1, wherein the articulating members are configured to allow the articulated position to include a primary curve.

4. An articulatable access system as in claim 3, wherein the primary curve has a radius of curvature in the range of approximately 0.125 in. to 1.000 in.

5. An articulatable access system as in claim 3, wherein the articulating members are configured to allow the articulated position to further include a secondary curve.

6. An articulatable access system as in claim 5, wherein the secondary curve has a radius of curvature in the range of approximately 0.050 in. to 0.750 in.

7. An articulatable access system as in claim 5, wherein the primary curve and secondary curve lie in different planes.

8. An articulatable access system as in claim 7, wherein the primary curve and secondary curve lie in substantially orthogonal planes.

9. An articulatable access system as in claim 5, wherein the distal end terminates in a distal tip and the at least one pullwire is fixedly attached to the distal tip to allow the distal tip to move through an angle theta.

10. An articulatable access system as in claim 9, wherein the secondary curve and the angle theta lie in different planes.

11. An articulatable access system as in claim 10, wherein the secondary curve and the angle theta lie in orthogonal planes.

12. An articulatable access system as in claim 9, wherein the primary curve, secondary curve and the angle theta each lie in different planes.

13. An articulatable access system as in claim 12, wherein the primary curve, secondary curve and the angle theta each lie in orthogonal planes.

14. An articulatable access system as in claim 1, wherein distal end is configured to be passable through a blood vessel to the body cavity.

15. An articulatable access system as in claim 14, wherein the body cavity comprises a chamber of a heart and the articulated position directs the central lumen toward a valve.

16. An articulatable access system as in claim 1 wherein the obturator is generally straight such that the first shape is generally straight.

17. An articulatable access system as in claim 1 wherein the obturator is articulatable such that the first shape has at least one curve.

18. An articulatable access system as in claim 1 wherein the obturator is flexible such that the shaft is positionable through the patient'"'"'s vasculature when the obturator is positioned in the central lumen.

19. An articulatable access system as in claim 1, wherein the at least one pullwire comprises four pullwires.

20. An articulatable access system as in claim 1, wherein the articulating members comprise interfitting domed rings.

21. An articulatable access system for accessing a body cavity comprising:

a shaft having a proximal end, a distal end, and a central lumen therethrough, wherein the distal end is passable through to the body cavity, the central lumen is sized for passage of an interventional device therethrough and a portion of the shaft comprises a series of interfitting articulating members;

at least one pullwire which extends through at least one of the articulating members to move the portion of the shaft into an articulated position;

an obturator removably positionable in the central lumen and configured to position the portion of the shaft in a first shape; and

a locking feature to hold the interfitting articulating members in the articulated position to direct the device to the body cavity.

22. An articulatable access system as in claim 21, wherein each of the articulating members is independently rotateable against an adjacent articulating members.

23. An articulatable access system as in claim 21, wherein the at least one pullwire comprises a first pullwire which is fixedly attached to the shaft at a primary attachment point so that applying tension to the first pullwire deflects the series of interfitting articulating members to form a primary curve.

24. An articulatable access system as in claim 23, wherein the primary curve has a radius of curvature in the range of approximately 0.125 in. to 1.000 in.

25. An articulatable access system as in claim 23, wherein the distal end terminates in a distal tip and the primary attachment point is located at the distal tip.

26. An articulatable access system as in claim 23, wherein the at least one pullwire further comprises a second pullwire which is fixedly attached to the shaft at a secondary attachment point so that applying tension to the second pullwire deflects the series of interfitting articulating members to form a secondary curve.

27. An articulatable access system as in claim 26, wherein the secondary curve has a radius of curvature in the range of approximately 0.050 in. to 0.750 in.

28. An articulatable access system as in claim 26, wherein the at least one pullwire further comprises a third pullwire which is fixedly attached to the shaft at a distal attachment point and so that applying tension to the third pullwire moves the distal end through an angle theta.

29. An articulatable access system as in claim 28, wherein the angle theta is in the range of −

100°

to +100°

degrees.

30. An articulatable access system as in claim 21, wherein each pullwire extends through the central lumen.

31. An articulatable access system as in claim 21, wherein each pullwire extends through a pullwire lumen in a wall the interfitting articulating members.

32. An articulatable access system as in claim 31 wherein the pullwire lumen is oblong.

33. An articulatable access system as in claim 21, wherein the at least one pullwire comprises eight pullwires.

34. An articulatable access system as in claim 21, wherein the locking feature comprises means for holding the at least one pullwire in a tensioned position so that the interfitting articulating members are compressed together.

35. An articulatable access system as in claim 21, wherein the locking feature comprises a frictional surface on at least a portion of the articulating members to enhance friction between the articulating members.

36. An articulatable access system as in claim 21, wherein the obturator further comprises a guidewire lumen configured to slidably receive a guidewire.

37. An articulatable access system as in claim 21 further comprising a hemostasis valve in communication with the central lumen adapted for inhibiting fluid flow therefrom, the hemostasis valve being configured to receive the interventional device and the obturator.

38. An access system for accessing a body cavity comprising:

a sheath comprising a shaft having a proximal end, a distal end and a central lumen therethrough, wherein the distal end is passable through to the body cavity and a portion of the shaft comprises a series of articulating members which are movable into an articulated position; and

an obturator sized for passage through the central lumen, at least a portion of the obturator being articulatable, wherein articulation of the obturator positions the articulating members of the sheath in the articulated position.

39. An access system as in claim 38, wherein each articulating members is independently rotatable relative to an adjacent articulating members.

40. An access system as in claim 38, further comprise a locking mechanism in the sheath to lock the articulating members in the articulated position.

41. An access system as in claim 40, wherein the locking mechanism comprises a pullwire extending through at least a portion of the articulating members and configured to compress the articulating members together.

42. An access system as in claim 38, wherein the obturator comprises at least one pullwire passing therethrough whereby exerting tension on the pullwire deflects the obturator.

43. An access system as in claim 38 wherein the sheath includes an articulation mechanism adapted to articulate the articulating members.

44. An access system as in claim 38, wherein the articulation mechanism comprises at least one pullwire extending through at least a portion of the articulating members.

45. An access system as in claim 38, wherein the articulated position comprises a primary curve.

46. An access system as in claim 45, wherein the articulated position further comprises a secondary curve.

47. An access system as in claim 46, wherein the primary curve and secondary curve lie in different planes.

48. An access system as in claim 38, wherein the obturator is removable such that the sheath remains in the articulated position upon removal of the obturator.

49. A method of performing a procedure at a treatment site in a body cavity comprising:

advancing a sheath to the body cavity, wherein the sheath comprises a shaft having a proximal end, a distal end, and a central lumen therethrough, a portion of the shaft comprising a series of articulating members, an obturator being removably positioned in the central lumen;

articulating the articulating members to move the portion of the shaft into an articulated position;

maintaining the articulating members in the articulated position;

removing the obturator from the central lumen; and

passing an interventional device through the central lumen, wherein the articulated position directs the interventional device to the treatment site.

50. A method as in claim 49, wherein the sheath further comprises at least one pullwire which extends through at least one of the articulating members, and wherein articulating the articulating members comprises applying tension to the at least one pullwire.

51. A method as in claim 50, wherein maintaining the articulating members comprises holding tension in the at least one pullwire.

52. A method as in claim 49 wherein the obturator further comprises at least one pullwire, and wherein articulating the articulating members further comprises applying tension to the at least one pullwire to deflect the obturator.

53. A method as in claim 49 wherein advancing the sheath comprises slidably positioning the sheath over a guidewire.

54. A method as in claim 50, wherein the articulated position includes a primary curve.

55. A method as in claim 54, wherein the primary curve has a radius of curvature in the range of approximately 0.125 in. to 1.000 in.

56. A method as in claim 54, wherein the articulated position further includes a secondary curve.

57. A method as in claim 56, wherein the secondary curve has a radius of curvature in the range of approximately 0.050 in. to 0.750 in.

58. A method as in claim 56, wherein the primary curve and secondary curve lie in different planes.

59. A method as in claim 56, wherein the distal end terminates in a distal tip and articulating the articulating members includes moving the distal tip through an angle theta to move the portion of the shaft into the articulated position, wherein the angle theta is in the range of −

100°

to +100°

degrees.

60. A method as in claim 59, wherein the primary curve, the secondary curve and the angle theta each lie in different planes.

61. A method as in claim 49 wherein the obturator is flexible, and wherein advancing the sheath comprises positioning the sheath through a curved path.

62. A method as in claim 49, wherein the body cavity comprises a left atrium.

63. A method as in claim 62, wherein advancing the sheath comprises positioning the sheath across the interatrial septum.

64. A method as in claim 62 wherein the distal end terminates in a distal tip and articulating the articulating members includes moving the portion of the shaft into the articulated position so that the distal tip is directed towards the mitral valve.

65. A method as in claim 49, further comprising:

wherein passing the interventional device through the central lumen includes passing the interventional device through an opening in the mitral valve.

66. A method of accessing a body cavity comprising:

advancing a sheath to the body cavity, wherein the sheath comprises a shaft having a proximal end, a distal end, and a central lumen therethrough, and a portion of the shaft comprises a series of articulating members;

passing an obturator through the central lumen;

articulating the obturator to position the articulating members in an articulated position;

locking the articulated members in the articulated position; and

removing the obturator to allow passage of an interventional device through the central lumen, wherein the articulated position directs the interventional device into the body cavity.

67. A method as in claim 66, wherein articulating the obturator further comprises applying forces to the central lumen to position the articulating members.

68. A method as in claim 67, wherein the articulated position includes a primary curve.

69. A method as in claim 68, wherein the articulated position further includes a secondary curve.

70. A method as in claim 69, wherein the primary curve and secondary curve lie in different planes.

71. A method as in claim 69, wherein the distal end terminates in a distal tip and articulating the obturator further comprises moving the distal tip through an angle theta to move the portion of the shaft into the articulated position.

72. A method as in claim 71, wherein the primary curve, secondary curve, and angle theta lie in different planes.

73. A method as in claim 66, wherein the obturator comprises at least one pullwire, wherein articulating the obturator comprises applying tension to the at least one pullwire.

74. A method as in claim 66, wherein the sheath comprises at least one pullwire which extends through at least one of the articulating members, and wherein locking the articulating members comprises holding tension in the at least one pullwire with a locking mechanism.

75. A method as in claim 66, wherein the body lumen comprises a blood vessel.

76. A method as in claim 75, wherein the body cavity comprises a left atrium.

77. A method as in claim 76, wherein advancing the sheath comprises passing the sheath through an intra-atrial septum.

78. A method as in claim 77, wherein the distal end terminates in a distal tip and articulating the articulating members includes moving the portion of the shaft into the articulated position so that the distal tip is directed towards the mitral valve.

79. A method as in claim 78, wherein passing the interventional device through the central lumen includes passing the interventional device through an opening in the mitral valve.

80. A kit for accessing a body cavity comprising:

an articulatable access system comprising

a shaft having a proximal end, a distal end, and a central lumen therethrough, wherein the distal end is passable to the body cavity, the central lumen is sized for passage of an interventional device therethrough and a portion of the shaft comprises a series of articulating members;

at least one pullwire which extends through at least one of the articulating members to move the portion of the shaft into an articulated position;

a locking feature to hold the articulating members in the articulated position to direct the device to the body cavity; and

instructions for using the articulatable access system, wherein the instructions set forth method steps including

advancing the sheath to the body cavity,

applying tension to the at least one pullwire to move the portion of the shaft into the articulated position;

maintaining the articulating members in the articulated position; and

passing an interventional device through the central lumen, wherein the articulated position directs the interventional device into the body cavity.

81. A kit as in claim 80, further comprising the interventional device.

82. A kit for accessing a body cavity comprising:

a sheath comprising a shaft having a proximal end, a distal end and a central lumen therethrough, wherein the distal end is passable to the body cavity and a portion of the shaft comprises a series of articulating members which are lockable in a fixed position; and

instructions for using the sheath, wherein the instructions set forth method steps including

advancing the sheath through a body lumen to the body cavity,

passing an obturator through the central lumen, wherein the obturator has means for articulating the obturator, wherein articulation of the obturator positions the articulating members in an articulated position which becomes the fixed position upon locking; and

articulating the obturator to position the articulating members in the articulated position;

locking the articulated members in the articulated position; and

removing the obturator to allow passage of an interventional device through the central lumen, wherein the articulated position directs the interventional device into the body cavity.

83. A kit as in claim 82, further comprising the obturator.

84. A kit as in claim 82, further comprising the interventional device.